A protein produced by certain types of white blood cells to deactivate foreign proteins.

Cytotoxic drugs used to treat cancers.

Protein that controls chemical reactions in the body.

A drug that attempts to modify the immune system.

A type of white blood cell that aids in the destruction of unwanted substances such as bacteria and dead cells.

A drug that promotes certain kinds of cellular activity by binding to a cell's receptor.

A drug that prevents certain types of cellular reactions by blocking other substances from binding to a cell's receptor.

A drug designed for the treatment of a rare disease afflicting a relatively small patient population with less than 200,000 cases.

The set of all proteins expressed by a genome.

The process of creating new DNA by combining components of DNA from different organisms. Usually, the new DNA is then incorporated into the therapeutic substances.

Rare proteins of the immune system that appear to destroy some kinds of tumor cells without affecting healthy cells.

A system whereby biological information is collected, stored, accessed, and analyzed via computers and related electronic media.

Biologics (also called Biologic drugs) are medicinal preparations made from living organisms or their byproducts. Vaccines, antigens, serums, and plasmas are examples of biologics.

Pharmacology tests typically consisting of three stages in which experimental drugs are administered to humans to determine their safety and efficacy before being submitted for regulatory approval and ultimately commercialization.

A family of proteins, including interferons, interleukins, and various growth factors, that bind to cellular receptors and are involved in the regulation of cell function.

The use of two or more drugs that together have greater therapeutic power in treating illness and disease than either used alone.

The basic determinant of heredity. Genes are chromosomal segments that direct the syntheses of proteins and conduct other molecular regulatory functions.

The introduction of specific genes into a patient's body to replace defective ones or to suppress the action of a harmful gene.

The total complement of genetic material in a cell comprising the entire chromosomal set found in each nucleus of a given species.

The study of genes and their functions including mapping genes with genomes, identifying their nucleic acid structures, and investigating their function.

Pituitary hormone that stimulates the growth of long bones in prepubertal children.

a variation in he sequence of a gene due to change in a single nucleotide.

Amino acids are molecules that are the building blocks of protein. There are 22 known, naturally occurring amino acids. These include nine essential amino acids that cannot be synthesized by the human body and must be obtained through dietary intake; and 13 non-essential amino acids that can be manufactured by the human body.

A drug that prevents certain types of cellular reactions by blocking other substances from binding to a cell's receptor.

A formal filing that biotechnology companies submit to the Food & Drug Administration for approval to market new biologics -based drugs. The application must contain clinical evidence of the compound's safety and efficacy.

The percentage of a drug's active ingredient that reaches a patient's bloodstream and body tissue.

A condition where the body produces antibodies against its own tissues.

A miniaturized technology that can be used to run hundreds of tests simultaneously. The chips are etched with genetic proteomic information and used by researchers to analyze DNA sequences , a certain gene or protein expression, or detect genetic abnormalities known as mutations.

A compound with a mechanism of action significantly superior than from existing drugs which represents a therapeutic advancement.

A generic copy of a biological molecule , developed using modern biotechnology techniques. A biosimilar drug has similar activity and is structurally nearly identical to the biologic that it copies . But a biosimilar drug is not truly identical and normally requires a different regulatory process than pharmaceutical generic drugs.

See Biosimilar…

Microscopic threadlike components in the nucleus of a cell that carry hereditary information in the form of genes.

Proteins involved in the normal clotting of blood.

Proteins responsible for controlling the production of white blood cells.

A scientific technique whereby DNA strands are decoded in order to quantify the exact order of DNA'S four nucleotides (A,C,G, &t). This allows scientists to analyze the sequence of strands and identify specific genes.

The formal filing that pharmaceutical companies submitted the FDA for approval to commercialize new chemical-based drugs. The drug application must contain clinical evidence of the compound's safety and efficacy.

A method of biological screening and diagnostic testing that entails amplifying DNA and RNA to identify diseaeses and infections.

An investigational drug receiving this status from the FDA will be reviewed by the agency within six months of its BLA or NDA submission rather than the standard 10 months.

Ribosomal nucleic acid plays an important role in protein production by carrying instructions from a cell's genes (DNA) to its protein-making apparatus . RNAi is a method that can be used to prevent RNA from delivering its messages which silences the gene blocking production of the protein.

The analysis of a drug's absorption and distribution in the body its chemical changes in the body, and how it is stored and eliminated in the human body.

A list of recommended medicines and dosages that health insurers are willing to cover. The drugs on formularies are grouped in categories which are defined by the extent to which payers want to encourage members to use those drugs over alternatives.

Synthetic versions of proteins manufactured using recombinant DNA technology and designed to block unwanted binding of cytokines to their cellular receptors.